The FDA yesterday rejected Newron’s drug, which is already approved in the EU, after controlled substance staff asked for a clinical evaluation on whether Xadago can be abused and its dependence or withdrawal effects.

Italy’s Newron said this does not require any new efficacy or safety data and is requesting a meeting with FDA staff to finalise plans for additional experiments.

Newron said it will provide an update, along with partners Zambon and Worldmeds, about a timeline for possible approval “in the near future”.

There was better news for Acadia, whose Nuplazid oral medicine for Parkinson’s disease pyschosis was backed by the FDA’s Psychopharmacologic Drugs Advisory Committee.

The committee voted 12 to two that the benefits of Nuplazid outweighed the risks of treatment in the indication.

The FDA is not bound by the Committee’s recommendation, but takes its advice into consideration when making regulatory decisions. The FDA is due to make a decision on Nuplazid by 1 May after a priority review.

Nuplazid, which the FDA has designated a breakthrough therapy as there are no approved drugs in this indication, was tipped to be a potential blockbuster in a Thomson Reuters report last month.

The annual Drugs to Watch study said Nuplazid was one of seven emerging blockbusters poised to enter the market this year, forecasting sales of $1.4 billion by 2020.